Multimodal, Enriched Environment for Rehabilitation in Chronic Traumatic Brain Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMetroHealth Medical Center
About this trial
The goal of this study is to learn if a enhanced environment (Metro Café) with multi model approach (an approach that combines several therapies) in chronic traumatic brain injury improves outcomes of recovery better than traditional therapy. The main questions it aims to answer are:
* Determine the amount of therapy dosage (speech, cognition, arm and leg movements) obtained during the Metro Café therapy session. * Evaluate the connection between environmental enrichment dosage (the Metro Café) and clinical outcome scores.
Researchers will compare Metro Café Treatment to those who do not receive this treatment to see if better improvements in function after a traumatic brain injury are seen in the Metro Café Treatment Participants will train in the Metro Cafe during the 2-month gap between assessments, for a total of 18 training sessions, each up to 2 hours, 3 times per week. Participants will greet and serve customers drinks and snacks, maintain food supplies at the counters and performs housekeeping tasks with advice and assistance from a supervising researcher as needed,
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
moderate to severe neurological diagnosis as diagnosed by a clinician,
ability to comprehend multi step instructions,
ability to independently balance with weight support,
physical deficits resulting in need for additional functional goals,
Disqualifiers
Adults unable to consent
Individuals who are not yet adults (infants, children, teenagers)
Non-English speaking
Pregnant women
Trial design
Design model
Parallel
Treatments tested in this trial
Cafe Therapy
BehavioralParticipants will be volunteer workers for two hours per day, three days per week for 6-8 weeks, alongside a trained researcher. Participants will complete at least 18 sessions of training within the time frame. Participants will run the Café with supervision from a researcher, serving customers prepackaged food and drinks per our protocol, along with guidance and direction from a therapist, once a week. Participants will be responsible for interacting with customers and arranging supplies. On a weekly basis, participants will be asked how they feel (for example tired, stressed, overwhelmed, etc) before and after their session and to rate how well they performed in the café.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Cafe TherapyExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Limb Motion Analysis
Preprocessing of data will be performed, and motion data will then be extracted. We will evaluate motion by single limb, namely: right arm, right leg, left arm, left leg. We will also combine across limbs: right arm, left arm, right leg, left leg, and over the whole-body amount of motion (AoM).
Time frame
Baseline, 10 weeks post treatmentSecondary outcomes
1
10 Meter Walk Test (10-MWT)
The total time taken to ambulate 6 meters (m) is recorded to the nearest hundredth of a second. 6 m is then divided by the total time (in seconds) taken to ambulate and recorded in m/seconds
Time frame
Baseline, 10 weeks post treatment2
Action Research Arm Test (ARAT)
The Action Research Arm Test (ARAT) is a 19-item measure aimed at assessing functional performance of the upper extremity through observational means.
Time frame
Baseline, 10 weeks post treatment3
Neuro - Qol(Quality of Life)
The NeuroQOL is a self-report of health related quality of life in 17 domains and sub-domains for adults and 11 for children with neurological disorders. The measure is available for administration via Computer Assisted Testing or in short forms (8-10 items) for each sub-domain that can be selected based on individual patient needs: * Neuro-QoL - Positive Affect and Well-Being the following Domains will be used: * Neuro-QoL - Lower Extremity Function * Neuro-QoL - Upper Extremity Function * Neuro-QoL - Sleep Disturbance * Neuro-QoL - Emotional and Behavioral Dyscontrol * Neuro-QoL - Fatigue * Neuro-QoL - Stigma Scale 1-5 (lower score better outcome) 1. \- Never 2. \- Rarely 3. \- Sometimes 4. \- Often 5. \- Always
Time frame
Baseline, 10 weeks post treatmentSponsors and contacts
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Source ClinicalTrials.gov